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AzTrials

Head and Neck CancerPhase 3BURANNCT04338399

The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC

A Phase 3 study testing Buparlisib & Paclitaxel in people with Head and Neck Cancer, run by Adlai Nortye Biopharma Co., Ltd. at 162 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Buparlisib & Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
487 participants
Where
162 sitesin 17 countries
Study dates
12 Dec 2020to 2 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥18 years old.
  • Able to provide informed consent obtained before any trial related activities and according to local guidelines.
  • Patient has histologically and/or cytologically-confirmed HNSCC.
  • Patient has archival or new tumor tissue for the analysis of biomarkers and confirmation of HPV status (if unknown). One tumor block (preferred) or a recommended minimum of 5 unstained slides for patients with known HPV status (for tumor DNA characterization) or a recommended minimum of 10 slides for patients whose HPV status is unknown (5 slides for HPV testing plus 5 slides needed for biomarker testing). Enrollment in the study is contingent on confirmation of the availability of an adequate amount of tumor tissue, except in rare special circumstances, which must be reviewed and approved by the sponsor.
  • Patient has either progressive or recurrent disease after treatment with PDL1/PD1 based therapy for recurrent or metastatic disease:
  • PDLl/PD1 therapy alone for metastatic (monotherapy) disease
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  • PDL1/PD1 in combination with chemotherapy for metastatic and recurrent disease
  • PDL1/PD1 used for metastatic disease, after or prior to receiving a platinum agent for locally advanced or metastatic disease.
  • 6. Patient has received no more than two prior lines of systemic treatment for HNSCC (single agent chemotherapy used as a radiosensitizer is not counted as a prior line of therapy).
  • Patient has measurable disease as determined per RECIST version 1.1. If the only site of measurable disease is a previously irradiated lesion, documented progression of disease and a four-week period since radiotherapy completion is required.
  • Patient has adequate bone marrow function and organ function as shown by the following:
  • Absolute neutrophil count (ANC) ≥1.5 x 109/L.
  • Hemoglobin ≥9 g/dL (which may be reached by transfusion).
  • Platelets ≥100 x 109/L (which may be reached by transfusion).
  • International normalized ratio (INR) ≤1.5.
  • Calcium (corrected for serum albumin) within normal limits (WNL) or ≤ grade 1 severity according to NCI-CTCAE version 5.0 if judged clinically not significant by the Investigator.
  • Patients concomitantly taking bisphosphonates or denosumab for calcium correction are eligible.
  • Normal potassium and magnesium levels.
  • Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤ 1.5 x upper limit of normal (ULN) or < 3.0 x ULN if liver metastases are present.
  • Total serum bilirubin ≤ ULN or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin below or within normal range in patients with well documented Gilbert's Syndrome. Gilbert's syndrome is defined as presence of episodes of unconjugated hyperbilirubinemia with normal results from cells blood count (including normal reticulocyte count and blood smear), normal liver function test results, and absence of other contributing disease processes at the time of diagnosis.
  • Serum creatinine ≤ 1.5 x ULN or calculated and directly measured creatinine clearance (CrCL) > 30 mL/min.
  • Haemoglobin A1c (glycosylated hemoglobin; HbA1c) ≤8%.
  • Patient has Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  • Patient is able to swallow and retain oral medication. Patients able to swallow oral medication but mostly self-nourished through gastric or jejunal feeding tube are eligible.
  • Patients must apply highly effective contraception during and throughout the study, as well after the final dose of study treatment

Who cannot join

  • Patients meeting any of the following criteria will not be eligible for participation in the study:
  • Patient has received previous treatment with any protein kinase B (PKB/AKT), mammalian target of rapamycin (mTOR) inhibitors, or phosphatidylinositol 3 kinase (PI3K) pathway inhibitors.
  • Patient received treatment with a taxane as part of prior treatment for metastatic disease.
  • Patient has symptomatic central nervous system (CNS) metastases. Patients with asymptomatic CNS metastases may participate in this study. Patient must have completed any prior local treatment for CNS metastases ≥ 28 days prior to the start of study treatment (including radiotherapy) and must be on a stable low dose of corticosteroid therapy. Radiosurgery must have been completed at least 14 days prior to start of study treatment.
  • Patient has received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study treatment or who have adverse events which have not recovered to grade 1 or better from previous chemotherapy treatment (except alopecia, autoimmune endocrine events must be stable and controlled).
  • Patient has grade ≥ 2 neuropathy, colitis, pneumonitis, , and uncontrolled endocrinopathies (e.g., hypothyroidism, diabetes with hemoglobin A1c > 8%) from previous treatment
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  • Patient has had major surgery within 14 days prior to starting study treatment or has not recovered from major side effects.
  • Patient is currently receiving increasing or chronic treatment (>5 days) with corticosteroids or another immunosuppressive agent. The following uses of corticosteroids are permitted: single doses; standard premedication for paclitaxel, topical applications (e.g., rash), inhaled sprays (e.g., obstructive airways diseases), eye drops, or local injections (e.g., intra-articular), or < 10 mg prednisolone or equivalent.
  • Patient is being treated at start of study treatment with any of the following drugs:
  • Drugs known to be strong or moderate inhibitors or inducers of isoenzyme cytochrome P450 3A4 (CYP3A4) including herbal medications (see Table 16).
  • Drugs with a known risk of inducing Torsades de Pointes. Note: The patient must have discontinued strong inducers for at least one week and must have discontinued strong inhibitors before the treatment is initiated. Switching to a different medication prior to starting study treatment is allowed.
  • Patient is currently receiving warfarin or other coumarin-derived anti-coagulant, for treatment, prophylaxis, or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), fondaparinux or new oral anticoagulants (NOACs) is allowed.
  • Patient has a known hypersensitivity and/or contraindication to paclitaxel, standard premedication for paclitaxel, or other products containing Cremophor®.
  • Patient has other concurrent severe and/or uncontrolled medical conditions that would, in the Investigator's judgment, contraindicate patient participation in the clinical study (e.g., active or uncontrolled severe infection, chronic active hepatitis, immunocompromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc).
  • Patient has a known history of human immunodeficiency virus (HIV) infection (testing not mandatory).
  • Patient has any of the following cardiac abnormalities:
  • Symptomatic congestive heart failure within 12 months of the screening period.
  • History of documented congestive heart failure (New York Heart Association functional classification III-IV) or documented cardiomyopathy and left ventricular ejection fraction (LVEF) <50% as determined by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO).
  • Myocardial infarction ≤six months prior to enrollment.
  • Unstable angina pectoris.
  • Serious uncontrolled cardiac arrhythmia.
  • Symptomatic pericarditis.
  • QT interval corrected according to the formula of Fridericia (QTcF) > 450 msec for males and > 470 msec for females, on the screening electrocardiogram (ECG).
  • Currently receiving treatment with medication that has a known risk to prolong the QT interval or inducing Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment.
  • Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study treatment (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
  • Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g., risk of doing harm to self or others), or active severe personality disorders (defined according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition [DSM-V]) are not eligible. Note: For patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous six weeks prior to start of study treatment.
  • Patient has other prior or concurrent malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, or other adequately treated in situ cancer, early gastric or GI cancer resected completely by endoscopy procedures or any other cancer from which the patient has been disease free for ≥ 3years.
  • Patient has a history of non-compliance to any medical regimen or inability to grant consent.
  • Patient is concurrently using or has used another approved or investigational cancer agent within 4 weeks of randomization.
  • Patient is pregnant or nursing (lactating). Patients with elevated human chorionic gonadotrophin (hCG) at baseline that is judged to be related to the tumor are eligible if hCG levels do not show the expected doubling when repeated five to seven days later, or pregnancy has been ruled out by vaginal ultrasound.
  • Patient has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (eg, Flu-Mist®) are live attenuated vaccines, and are not allowed. Non-live COVID vaccinations or boosters should not occur within 30 days of study start.

Trial locations and contacts

162 sites in 17 countries.

162 sites in 17 countries

Spain27 sites

  • Fundacion Oncologico de Galicia Jos Antonio Quiroga y Pieyro

    A Coruña, 15009

  • Institut Catala d Oncologia Badalona

    Badalona, 08916

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Vall dHebron Institute of Oncology (VHIO)

    Barcelona, 08035

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Universitario de Burgos

    Burgos, 09006

  • Hospital Reina Sofia

    Córdoba, 14004

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Hospital Duran i Reynals - Institut Catala dOncologia ICO

    L'Hospitalet de Llobregat, 08908

  • Hospital Universitario Severo Ochoa

    Leganés, 28911

  • Hospital Universitario Lucus Augusti

    Lugo, 27003

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Clinico Universitario Virgen de la Arrixaca

    Madrid, 30120

  • Hospital General Universitario Gregorio Maran

    Madrid

  • Hospital Puerta de Hierro- Majadahonda

    Majadahonda, 28220

  • Hospital Regional de Malaga

    Málaga, 29010

  • Hospital de Navarra

    Pamplona, 31008

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Universitario Santiago de Compostela

    Santiago de Compostela, 15706

  • Valme Hospital Medical Oncology Department

    Seville, 41014

  • Instituto Valenciano de Oncologia

    Valencia, 46009

  • Hospital Clinico Universitario Valencia - INCLIVA

    Valencia, 46010

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

United States21 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Cincinnati Cancer Center

    Cincinnati, Ohio, 45219

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • City of Hope

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • West Cancer Center

    Germantown, Tennessee, 38138

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Yale University, Yale Cancer Center

    New Haven, Connecticut, 06511

  • NYU Langone

    New York, New York, 10016

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Washington University School of Medicine

    St Louis, Missouri, 63130

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Hope Cancer Center, UT Health East Texas

    Tyler, Texas, 75701

Other trials in United States

Italy20 sites

  • Azienda Ospedaliera Universitaria S.Orsola-Malpighi

    Bologna, 40138

  • ASST Spedali Civili Brescia

    Brescia, 25123

  • Istituto di Candiolo IRCCS

    Candiolo, 10060

  • IRCCS - Istituto Scientifico Romagnolo per la Cura e lo Studio dei Tumori

    Cesena

  • A.O. S. Croce e Carle

    Cuneo, 12100

  • Azienda Ospedaliero Universitaria Careggi - Firenze

    Florence, 50134

  • Istituto Nazionale dei Tumori

    Milan, 20133

  • Azienda Ospedaliera San Paolo Polo Universitario

    Milan, 20142

  • INT IRCCS Fondazione G.Pascale

    Naples, 80131

  • A.O.U. "Maggiore della Carita"- S.C.D.U Oncologiac

    Novara, 28100

  • Azienda Ospedaliero Universitaria Policlinico "Paolo Giaccone" U.O.C. Oncologia Medica

    Palermo, 90127

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126

  • IRCCS Maugeri Pavia

    Pavia, 27100

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20089

  • AOU San Giovanni di Dio e Ruggi D'Aragona, Università degli Studi di Salerno

    Salerno, 84131

  • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

    Siena, 53100

  • ASST Valtellina e Alto Lario - UOC Oncologia Medica Ospedale di Sondrio

    Sondrio, 23100

  • AO Card. G. Panico

    Tricase, 73039

  • Azienda Sanitaria Universitaria Integrata di Udine

    Udine, 33100

  • Azienda Ospedaliera Universitaria Integrata Verona

    Verona, 37126

Other trials in Italy

China18 sites

  • Beijing Tongren Hospital

    Beijing, 100176

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, 233004

  • Hunan Cancer Hospital

    Changsha, 410000

  • Xiangya Hospital Central South University

    Changsha, 410000

  • Sichuan Cancer Hospital

    Chengdu, 610042

  • Affiliated Cancer Hospital of Chongqing University

    Chongqing, 400000

  • The First Affiliated Hospital of CQMU

    Chongqing, 400042

  • Sun Yat-sen University Cancer Center

    Guangzhou, 510000

  • Affiliated Cancer Hospital of Guangzhou Medical University

    Guangzhou, 510095

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Anhui Provincial Cancer Hospital

    Hefei, 230031

  • Shandong Provincial Tumor Hospital

    Jinan, 250000

  • Yunnan Cancer Hospital

    Kunming, 650000

  • Cancer Hospital affiliated to Guangxi Medical University

    Naning, 530021

  • Shanghai Dongfang Hospital

    Shanghai, 310115

  • Tianjin Cancer Hospital

    Tianjin, 300202

  • Henan Cancer Hospital

    Zhengzhou, 450000

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, 519000

Other trials in China

Japan14 sites

  • Hyogo Cancer Center

    Akashi-shi, 673-8558

  • National Cancer Center Hospital

    Chūōku, 104-0045

  • Kyushu University Hospital

    Fukuoka, 812-8582

  • Saitama Medical University International Medical Center

    Hidaka, 350-1298

  • Kagawa University Hospital

    Kita-gun, 761-0793

  • Kobe University Hospital

    Kobe, 650-0017

  • The Cancer Institute Hospital of JFCR

    Kōtoku, 135-8550

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, 791-0280

  • Aichi Cancer Center

    Nagoya, 464-8681

  • Kindai University Hospital

    Osaka Sayama-shi, 589-8511

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • National University Corporation Tohoku University, Tohoku University Hospital

    Sendai, 980-8574

  • Showa University Hospital

    Shinagawa-Ku, 142-8666

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

Other trials in Japan

France12 sites

  • Centre hospitalier Universitaire de Bordeaux

    Bordeaux, 33075

  • Centre Franois Baclesse

    Caen, 14000

  • Centre Leon Berard

    Lyon, 69008

  • Hopital de la Timone

    Marseille, 13005

  • Institut regional du Cancer de Montpellier

    Montpellier, 34298

  • LHopital prive du Confluent Nantes

    Nantes, 44277

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200

  • Hôpital St-Louis

    Paris, 75010

  • Hopital La Pitie Salpetriere

    Paris, 75013

  • Hopital Tenon

    Paris, 75970

  • CHP Saint-Grégoire

    Saint-Grégoire, 35760

  • Institut de cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54500

Other trials in France

Germany11 sites

  • Uniklinik RWTH Aachen

    Aachen, 52074

  • Universitaetsklinikum Bonn

    Bonn, 53127

  • University Hospital Essen

    Essen, 45147

  • Franziskus Hospital

    Georgsmarienhütte, 49124

  • HNO-Klinik des Universitats-Klinikums Giessen

    Giessen, 35392

  • Universitatsmedizin Greifswald - KoR

    Greifswald, 17489

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20246

  • Marienkrankenhaus Hamburg

    Hamburg, 22045

  • Hannover Medical School

    Hanover, 30625

  • Universitatsklinikum Leipzig

    Leipzig, 04103

  • UNIVERSITÄTSMEDIZIN Mainz III. Klinik/Poliklinik

    Mainz, 55131

Other trials in Germany

South Korea8 sites

  • Kosin University Gospel Hospital

    Busan, 49267

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620

  • Korea University Anam Hospital

    Seoul, 2841

  • Asan Medical Center

    Seoul, 5505

  • The Catholic University of Korea Seoul ST. Mary's Hospital

    Seoul, 6591

  • Korea University Guro Hospital

    Seoul, 8308

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Taiwan7 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Chang Gung Memorial Hospital-KaohSiung

    Kaohsiung City, 833

  • Taichung Veterans General Hospital

    Taichung, 40705

  • National Cheng Kung University Hospital

    Tainan, 704017

  • Chi Mei Medical Center Liouying

    Tainan, 73657

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital-LinKou

    Taoyuan, 33342

Other trials in Taiwan

Argentina6 sites

  • Fundacion Cenit para la Investigacion en Neurociencias

    Buenos Aires, 1125

  • Centro de Investigacion Pergamino SA - Clinica Pergamino S.A.

    Buenos Aires, B2700CPM

  • Instituto de Investigaciones Metabólicas (IDIM) // Instituto de Investigaciones Metabólicas S.A.

    Ciudad Autonoma de Buenos Aire, C1012AAR

  • IONC SRL- Instituto Oncológico de Córdoba

    Córdoba, X5002HWE

  • Fundacion CORI para la Investigacion y Prevencion del Cáncer

    La Rioja, F5300COE

  • Centro para la Atencion Integral del Paciente Oncologico - CAIPO

    San Miguel de Tucumán, T4000GTB

Other trials in Argentina

United Kingdom5 sites

  • Edinburgh Cancer Center

    Edinburgh, EH4 2XU

  • Beatson Oncology Centre

    Glasgow, G12 0YN

  • University College London Hospitals

    London, NW1 2BU

  • The Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • The Royal Marsden NHS Foundation Trust - Sutton

    Sutton, SM2 5PT

Other trials in United Kingdom

Belgium4 sites

  • Universitair Ziekenhuis Gent UZ Gent

    Ghent, 9000

  • Universitair Ziekenhuis Brussel

    Jette, 1090

  • Clinique CHC MontLégia

    Liège, 4000

  • Clinique Saint-Pierre dOttignies CSPO

    Ottignies, 1340

Other trials in Belgium

Hungary3 sites

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • University of Pecs Department of Oncotherapy

    Pécs, 7624

  • Tolna Megyei Balassa Janos Korhaz

    Szekszárd, 7100

Other trials in Hungary

Canada2 sites

  • CHUM

    Montreal, H2X 0C2

  • CancerCare Manitoba

    Winnipeg, R3E 0V9

Other trials in Canada

Poland2 sites

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie

    Gliwice, 44-102

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

Australia1 site

  • Princess Alexandra Hospital

    Brisbane, 4102

Other trials in Australia

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: The BURAN Study of Buparlisib (AN2025) In Combination With Paclitaxel Compared to Paclitaxel Alone, in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The BURAN study is a randomized, open-label phase III study to assess the treatment effect of once-daily buparlisib in combination with weekly paclitaxel compared to weekly paclitaxel alone in patients with refractory, recurrent, or metastatic head and neck squamous cell carcinoma (HNSCC) that have progressed after prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy.

Read the detailed description

This study is to assess the impact on overall survival of the combination of Buparlisib and paclitaxel compared to paclitaxel alone in patients with prior anti PD 1/anti PD L1 monotherapy; prior anti PD 1/anti PD L1 therapy in combination with platinum-based therapy; or after sequential treatment of anti PD 1/anti PD L1 therapy, either prior to or post, platinum-based therapy.

Being tested
Buparlisib & Paclitaxel
Keywords
Buparlisib, PD1, PDL1
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Buparlisib & PaclitaxelDrug

    Also called AN2025

    Investigation drug plus paclitaxel

Study groups in NCT04338399
Study groupRoleWhat they receive
Buparlisib & Weekly PaclitaxelExperimentalDrug: Patients will receive 100 mg (2 x 50 mg) buparlisib hard gel capsule administered orally, once daily starting on Day 1 of Treatment Cycle 1, Drug: Paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle. Treatment will continue until disease progression, unacceptable toxicity, death or discontinuation for any other reason.
Weekly PaclitaxelActive comparatorPatients will receive weekly paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 21-day treatment cycle. Treatment will continue until disease progression, unacceptable toxicity, death or discontinuation for any other reason.
Receives: Drug: Buparlisib & Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival (OS)

    To assess the OS of buparlisib in combination with paclitaxel compared to paclitaxel alone in patients with recurrent or metastatic HNSCC

    Measured: Overall survival will be measured from time of randomization until death from any cause. The analysis will occur when all patients have been randomized and followed for 12 months.

Secondary outcomes (5)

  1. Progression free survival

    Defined as the time from randomization date until tumor progression or death from any cause.

    Measured: PFS will be assessed up to 24 months after all patients are randomized

  2. Overall Response Rate

    Defined at the proportion of patients with a complete or partial response

    Measured: ORR will be assessed for all patients 6 months after randomization is complete.

  3. Health Related Quality of Life (QoL): Time to Definitive deterioration of Quality of Life as assessed by EORTC C30 questionnaire

    A summary of EORTC-QLQ-C30 scores by time window. Time to deterioration is the number of days between the date of randomization and the date of the assessment when definitive deterioration is seen. Definitive deterioration is defined as a decrease in the sub scale score by at least 10% compared with baseline.

    Measured: Assessments will be made from randomization until treatment discontinuation

  4. Safety and Tolerability of Buparlisib in combination with Paclitaxel compared with Paclitaxel alone as Measured by Number of Participants Experiencing Adverse Events (AEs).

    Treatment Emergent Adverse Events AEs will be assessed according to the NCI-CTCAE version 5.0 for severity and will be recorded and classified on the basis of MedDRA terminology.

    Anxiety score change from baseline taken at time of screening (General Anxiety Disorder 7 item scale) until end of treatment.

    Depression score change from baseline taken at time of screening (Patient Health Questionnaire 9) until end of treatment.

    Measured: From screening until 4 weeks following treatment discontinuation

  5. Pharmacokinetics of Buparlisib: plasma concentration-time profile of Buparlisib during 15 days of treatment

    For Sparse PK sampling, blood samples will be collected on Treatment Cycle 1, Days 1, 8, and 15 at pre-dose, 1 (± 0.25), 2 ± (0.25) and 6 ± (0.5) hours post-dose. PK sampling will be collected only for those patients randomized to the buparlisib in combination with paclitaxel arm and pharmacokinetic profile of Buparlisib combined with paclitaxel in the study population will be compared with a simulated population PK model.

    Measured: Day 0 to Day 15 sparse sampling

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2020
  2. Study start12 Dec 2020
  3. Primary completion2 Nov 2025
  4. Study completion2 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
487 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04338399
Sponsor's protocol ID
AN2025H0301
Acronym
BURAN
Status last verified
Nov 2025
First submitted
18 Mar 2020
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Buparlisib & Paclitaxel in people with Head and Neck Cancer, run by Adlai Nortye Biopharma Co., Ltd. at 162 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in Spain, United States, Italy, China, Japan and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Overall survival will be measured from time of randomization until death from any cause. The analysis will occur when all patients have been randomized and followed for 12 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04338399.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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